CN103002840B - An apparatus and method for diverting biliopancreatic juices discharged into a patient's intestinal tract - Google Patents

An apparatus and method for diverting biliopancreatic juices discharged into a patient's intestinal tract Download PDF

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Publication number
CN103002840B
CN103002840B CN201080068086.1A CN201080068086A CN103002840B CN 103002840 B CN103002840 B CN 103002840B CN 201080068086 A CN201080068086 A CN 201080068086A CN 103002840 B CN103002840 B CN 103002840B
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bile
food
distal
proximal
apparatus
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CN201080068086.1A
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CN103002840A (en
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A·帕斯托雷利
M·S·齐纳
T·E·亚尔布雷彻特
D·N·拉德
M·S·奥尔蒂茨
M·J·斯托克斯
C·J·赫斯
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伊西康内外科公司
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Priority to PCT/EP2010/060278 priority Critical patent/WO2012007048A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/0076Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

本发明公开了一种用于转移被排到患者肠道中的胆胰液的设备(11),所述设备(11)包括具有内部食物隔离空间(13)和近侧密封部分(14)、侧向开放式胆汁隔离腔(19)的管状构件(12)、食物套管部分(21)和胆汁转移导管(24),侧向开放式胆汁隔离腔(19)能够与肠壁的相邻部分一起限定胆汁隔离空间(19),食物套管部分(21)从柔性的管状构件(12)朝远侧延伸,胆汁转移导管(24)从胆汁隔离腔(19)沿远侧方向延伸并具有远侧开放式胆汁导管端(25)。 The present invention discloses an apparatus for transferring bile pancreatic juice is discharged to the intestinal tract of a patient (11), the device (11) comprises (13) and a proximal sealing portion (14) having an interior space isolated from food, laterally open bile isolation chamber (19) of the tubular member (12), food sleeve portion (21) and bile transfer conduit (24), open laterally bile isolation chamber (19) able to define together with the adjacent portion of the wall bile insulation space (19), food sleeve portion (21) extending from the flexible tubular member (12) distally, bile transfer conduit (24) extending from the bile isolation chamber (19) in a distal direction having a distal opening, and formula bile duct end (25).

Description

用于转移被排到患者肠道中的胆胰液的设备和方法 It is discharged for transferring apparatus and method pancreatic bile in the intestinal tract of patients

技术领域 FIELD

[0001] 本发明整体涉及如下装置和方法,所述装置和方法用于以外科手术方式影响患者的消化,其旨在治疗代谢紊乱,例如病态肥胖症以及相关的并存病(例如,糖尿病)、心脏病、中风、肺疾病和偶发病症。 [0001] The present invention generally relates to apparatus and method, the apparatus and method for surgically affect digestion of a patient, which is intended treatment of metabolic disorders, e.g. morbid obesity and related co-morbidities (e.g., diabetes), heart disease, stroke, lung disease and sporadic disorders.

背景技术 Background technique

[0002] 已经尝试许多用于病态肥胖症的非手术疗法,但事实上均没有获得持久性的成功。 [0002] Many attempts have been made non-surgical therapy for morbid obesity, but in fact did not get persistent success.

[0003] 治疗病态肥胖症的外科手术方法,例如针对持久性食物吸收不良的开放式、腹腔镜式和腔内胃旁路手术,已得到日益广泛的应用并且获得了较大成功。 [0003] The surgical method of treatment of morbid obesity, such as an open, laparoscopic and endoluminal gastric bypass surgery for persistent malabsorption of food, has been increasingly widely used and gained great success. 然而,目前用于执行胃旁路术的方法涉及耗时的且高灵敏度依赖性的外科手术技术以及对患者的胃肠解剖结构的显著且通常不利的修改。 However, a method for performing gastric bypass surgery involves time-consuming and highly sensitive dependence of surgical techniques, and is generally significant and adverse changes in the anatomy of the patient parenterally.

[0004] 为了避免胃旁路手术的缺点并且以更具体且有针对性的方式来影响患者的消化,本发明着重研究用于主要影响和调整肠-肝胆汁循环而非消化道的方法和装置。 The method and apparatus of the digestive tract rather than the hepatic circulation of bile - [0004] To avoid the disadvantages of gastric bypass surgery and more specific and targeted way to digest the patient's influence, the present invention focuses on the main effect for intestinal adjustment and . 为此,应当设想到作用于肠-肝胆汁循环的下述可能方法和机制: For this purpose, it is contemplated that in the intestinal - the following possible ways and mechanisms of hepatic bile cycle:

[0005]-调整肠-肝胆汁循环频率,尤其是胆汁循环加速度; [0005] - adjusting the intestine - liver bile cycle frequency, in particular, bile acceleration cycle;

[0006]-调整由胆汁与肠内的食物的接触和相互作用以及由胆汁与肠壁的接触而触发的生理信号; [0006] - adjustment of the contact and the interaction with the food, bile and intestinal physiological signals from the contact with the intestinal wall of the bile triggered;

[0007]-通过调整胆汁与食物或食糜在肠内的接触空间和接触时间以及通过使胆汁与食物有针对性地分离来调整食物的可吸收性。 [0007] - or by adjusting the bile with food and chyme contacting the contact space and adjusting the intestines by the food and food bile targeted separation may absorbency.

[0008] 用于将消化液例如胆汁和胰液朝远侧转移到小肠内的已知装置和方法已在US2009/0062717和US 7,314,489中有所论述。 [0008] for example, bile and pancreatic juice digestive distally to the known apparatus and method for transferring small intestine has been discussed in US2009 / 0062717 and in US 7,314,489. 公开于US 7,314,489中的装置包括支架,所述支架具有远端和接合乏特氏壶腹区域中的十二指肠的近端、以及位于近端和远端之间以产生可收集胆汁的环带体积的减小直径部分。 Disclosed in US 7,314,489 between the apparatus comprises a stent, the stent having a proximal end and a distal end engaging ampulla of Vater region duodenum, proximal and distal ends and positioned to produce a reduced diameter portion of the annulus volume collected bile. 公开于US 2009/0062717中的装置包括支承架和导管,所述支承架具有侧面开口,所述导管在连接到侧面开口的近端与远侧开口端之间延伸,其中所述导管的近端可形成贮存器。 Apparatus is disclosed in US 2009/0062717 comprises a support frame and a catheter, said support frame having a lateral opening, said conduit extending between a proximal end connected to the side opening of the distal end opening, wherein the proximal end of the catheter may form a reservoir.

[0009] 用于转移消化液的这些已知装置和方法收集胆汁,但它们并不具体地影响或改变胆汁和食物与肠壁接触和相互作用的时间和空间。 These known devices and methods [0009] for transferring the collected bile digestive juices, but they do not affect or alter the particular time and space bile and food contact and an interaction with the intestinal wall.

[0010] 因此本发明的目的为改变胆汁和食物与肠壁接触和相互作用的自然时间和空间,以引起重量减轻和/或允许以尤其微创的方式来控制糖尿病。 [0010] Therefore object of the present invention to vary with the intestinal bile and food contact and an interaction space and natural time, to cause the reduction and / or to allow a minimally invasive way to control, especially diabetes, by weight.

[0011] 通过用于转移被排到患者肠道中的胆胰液的设备来实现此目的,所述设备包括: [0011] The apparatus is discharged intestinal bile pancreatic juice by for transferring a patient to achieve this object, the apparatus comprising:

[0012] A)柔性的管状构件,所述管状构件具有: [0012] A) a flexible tubular member, said tubular member having:

[0013]-内部食物隔离空间和 [0013] - the internal space and food isolation

[0014]-近侧密封部分,所述近侧密封部分能够接合肠壁以防止食物在管状构件和肠壁之间流动, [0014] - sealing a proximal portion, the proximal portion can engage the sealing wall in order to prevent the food from flowing between the tubular member and the wall,

[0015]-近侧开口端,所述近侧开口端能够接纳食物流并且将食物流引导至食物隔离空间中, [0015] - a proximal open end, said open proximal end is capable of receiving food and the food stream flow to the food in the insulating space,

[0016]-远侧开口端,所述远侧开口端能够从食物隔离空间释放食物流, [0016] - a distal open end, said open distal end capable of releasing a flow of food from food insulation space,

[0017]-侧向开放式胆汁隔离腔,所述侧向开放式胆汁隔离腔由管状构件的外表面形成并且能够与肠壁的相邻部分一起限定胆汁隔离空间, [0017] - Bile isolation chamber open side, the open side of bile isolated cavity formed by the outer surface of the tubular member and bile can define together with the adjacent portion of the insulation space of the wall,

[0018] B)食物套管部分,所述食物套管部分从柔性的管状构件的远侧开口端朝远侧延伸并具有开放式远侧食物套管端,所述食物套管部分在内部限定食物输送空间, [0018] B) Food sleeve portion, the sleeve portion extending from the food distal opening end of the flexible tubular member distally and the sleeve has an open distal end of the food, the food inside the sleeve portion defined food delivery space,

[0019] C)胆汁转移导管,所述胆汁转移导管从胆汁隔离腔朝远侧延伸并具有开放式远侧胆汁导管端,所述胆汁转移导管在内部限定与所述食物输送空间隔离的胆汁输送空间。 [0019] C) transferring the bile duct, the bile from the bile transfer conduit distally extending isolation chamber having an open distal end of the bile duct, the bile transfer conduit defining the inside space of the food transport conveyor isolated bile space.

[0020] 此设备将食物或食糜与肠壁在管状构件远侧的区域中隔离,同时将胆汁从胆汁隔离腔且不进入奥狄括约肌而转移到独立于与食糜隔离的区域的位置(开放式胆汁导管端)O [0020] This device will chyme food or with the intestinal wall in the region of the tubular member distal isolation while the bile from the bile into the isolation chamber and not be transferred to the sphincter of Oddi independent and isolated regions chyme position ( bile duct open end) O

发明内容 SUMMARY

[0021] 根据本发明的一个方面,胆汁转移导管的远侧开口端定位在远侧开放式套管端的远侧的位置处。 [0021] In accordance with one aspect of the present invention, the distal opening of the bile transfer conduit is positioned at a location of the distal end of the cannula distal open end.

[0022] 这允许在柔性的管状构件远侧的第一位置分配食物以使食物接触肠壁,并且允许在第一位置更远侧的肠内第二位置分配胆汁或胆胰液,以使得胆汁与肠壁接触(例如,远侧空肠或回肠壁)并且在食糜流已沿肠道移行且接触与胆汁隔离的肠道之后,与部分消化的食物和食糜流接触。 [0022] This allows the distribution of food in the first position of the flexible tubular member such that the distal wall food contact, in the first position and allow a more distal intestine in bile or bile second dispensing position pancreatic juice, bile and such contacting the intestinal wall (e.g., distal jejunum wall or back) and after migration along the intestinal chyme has flow and in contact with the intestinal bile isolated, partially digested in contact with food and chyme stream. 因此,相对于自然状态而言,食物-胆汁-肠的接触空间和时间得到显著改变,从而影响食物吸收和肠肝胆汁循环以获得体重减轻和/或糖尿病的控制。 Thus, with respect to the natural state, the food - bile - intestinal contact time and spatial change significantly, thereby affecting food absorption and enterohepatic circulation of bile to obtain the control weight loss and / or diabetes.

[0023] 根据本发明的另一个方面,胆汁转移导管包括外部套,所述外部套限定围绕食物套管部分的环形胆汁输送空间。 [0023] According to another aspect of the invention, transfer conduit comprises an outer sleeve bile, the bile outer sleeve defining an annular space surrounding the food conveying section of the sleeve.

[0024] 根据本发明的另一个方面,胆汁输送空间由食物套管部分的外表面和周围肠壁部分限定,以使得胆汁以与食物流隔离但与肠壁接触的方式从管状构件朝远侧流入肠道内。 [0024] According to another aspect of the invention, the bile transport space by the outer surface of the sleeve portion and a peripheral wall portion defining a food, such as to the bile in contact with the intestinal wall but isolated from the flow of food and distally from the tubular member flow into the intestine.

[0025] 根据本发明的另一个方面,胆汁转移导管包括布置在食物套管部分外部的导管,以允许隔离的胆汁独立于肠壁和食糜流动。 [0025] According to another aspect of the invention, the bile transfer conduit comprises a portion of the outer sleeve is disposed in a food conduit, to permit independent isolated bile and intestinal digesta flow.

[0026] 根据本发明的另一个方面,食物套管部分直接从近侧密封部分延伸,从而形成十二指肠套管。 [0026] According to another aspect of the invention, the food sleeve portion extends directly from the proximal sealing portion, thereby forming a duodenal cannula.

[0027] 根据本发明的另一个方面,胆汁导管的远侧开口端在远端开口套管端近侧的位置处通入食物套管部分,由此允许: [0027] According to another aspect of the present invention, the bile duct at a location distal opening at the distal end of the cannula into the proximal open end of the sleeve portion of food, thereby allowing:

[0028]-胆胰液和食物流入第一部分,其中这两者彼此隔离并且与管腔壁隔离; [0028] - bile and pancreatic juice flowing in the first portion of food, wherein both isolated from each other and isolated from the lumen wall;

[0029]-胆胰液与食物流在位于第一部分远侧且仍与管腔壁隔离的第二部分中混合; [0029] - bile and pancreatic juice in the food stream mixing a second portion located distal of the first portion and is still isolated from the lumen wall;

[0030]-食物和胆胰液在第二部分远侧的位置处与肠壁接触。 [0030] - food pancreatic juice and bile distal portion of the second contact with the intestinal wall at a position.

[0031] 根据本发明的另一个方面,所述设备包括在近端和远端之间延伸的胆汁引流导管,所述近端具有支架以连接胆管树中的胆汁引流导管,所述远端连接与胆汁隔离腔流体连通的管状构件。 [0031] According to another aspect of the invention, the device comprises a biliary drainage catheter between the proximal and distal ends, said stent having a proximal end connected to biliary drainage catheters biliary tree, the distal connector bile tubular member in fluid communication with the isolation chamber. 这允许选择性地捕集胆管树内的胆汁和/或胰液并将其引导至胆汁隔离腔中。 This allows to selectively trap bile and / or pancreatic juice in the biliary tree and is guided to the bile isolation chamber.

[0032] 本发明的上述目的还通过用于转移被排到患者肠道中的胆胰液的方法实现,所述方法包括: [0032] The object of the present invention is also a method bile pancreatic juice is discharged to the intestinal tract of a patient for the transfer is achieved by the method comprising:

[0033] A)在乏特氏壶腹区域处形成位于装置和肠壁之间的胆汁隔离空间; [0033] A) forming a bile insulating space between the device and the wall located in the region of the ampulla of Vater;

[0034] B)将食物流与肠壁在胆汁隔离空间远端的区域中分离; [0034] B) separating the food stream with the intestinal wall in the region of the distal end of the bile insulating space;

[0035] C)将隔离的胆汁从胆汁隔离空间转移到其中食物流与肠壁分离的区域的远侧的位置。 [0035] C) isolating the bile from the bile insulation space to a transfer position where the distal wall of the food stream of separate regions.

[0036] 根据本发明的一个方面,转移隔离的胆汁的步骤包括如下步骤:将胆汁转移导管在腔内从胆汁隔离空间沿远侧方向延伸到其中食物流与肠壁分离的区域的远侧的位置。 [0036] In accordance with one aspect of the present invention, the step of transferring the isolated bile comprising the steps of: transferring the bile from the bile duct lumen extending in the distal direction insulation space wherein the food stream to the distal region of the separation wall position.

[0037] 根据本发明的另一个方面,转移隔离的胆汁的步骤包括如下步骤:通过肠-肠吻合或通过肠-内源组织管-肠吻合在胆汁隔离空间中的肠壁与肠的远侧靶位置之间形成直接管腔连通。 [0037] According to another aspect of the present invention, the step of transferring the isolated bile comprising the steps of: through the gut - intestinal anastomosis or by - endogenous tissue tube - anastomosis isolated space in the bile and gut distal wall a lumen in direct communication between the target position.

附图说明 BRIEF DESCRIPTION

[0038] 通过附图及其说明,本发明的这些和其它方面和优点将变得明显,所述附图及其说明示出了本发明的实施例,并连同上面给出的本发明的整体描述以及下文给出的实施例的具体实施方式用于解释本发明的原理。 [0038] The description and the drawings These and other aspects and advantages of the invention will become apparent from the accompanying drawings and the description thereof illustrate an embodiment of the present invention, and the present invention is given above in conjunction with the entire DETAILED dESCRIPTION Example embodiments given below, serve to explain and describe the principles of the present invention.

[0039]-图1示出了根据本发明的第一实施例的用于转移被排到患者肠道中的胆胰液的方法和设备; [0039] - Figure 1 illustrates a method and apparatus for patients with intestinal bile pancreatic juice in accordance with the first embodiment for transferring embodiment of the present invention is discharged;

[0040]-图2示出了图1中的设备的细节; [0040] - figure 2 shows a detail of the apparatus of Figure 1;

[0041]-图2A示出了根据本发明的第二实施例的设备的细节; [0041] - Figure 2A shows a detail of a second embodiment of the apparatus of the present invention;

[0042]-图3示出了根据本发明的第三实施例的设备的细节; [0042] - Figure 3 shows a detail of the apparatus of the third embodiment of the present invention;

[0043]-图4示出了根据本发明的第四实施例的设备的细节; [0043] - Figure 4 shows a detail of the device of the fourth embodiment of the present invention;

[0044]-图5示出了根据本发明的第五实施例的设备的细节; [0044] - Figure 5 shows a detail of the device according to a fifth embodiment of the present invention;

[0045]-图6-12示出了根据本发明的实施例的用于将设备锚定到胃肠道中的装置和方法; [0045] - Figures 6-12 illustrate apparatus and methods of the gastrointestinal tract to the anchoring device according to an embodiment of the present invention;

[0046]-图13示出了根据本发明的第六实施例的设备的细节; [0046] - Figure 13 shows a detail of the apparatus according to a sixth embodiment of the present invention;

[0047]-图14示出了根据本发明的第七实施例的设备的细节; [0047] - Figure 14 shows a detail of the device according to the seventh embodiment of the present invention;

[0048]-图15A和15B示出了根据本发明的第八实施例的设备的细节; [0048] - Figures 15A and 15B illustrate details of the apparatus of the eighth embodiment of the present invention;

[0049]-图16示出了根据本发明的另一个实施例的设备的细节; [0049] - Figure 16 shows a detail of an embodiment of apparatus according to another embodiment of the present invention;

[0050]-图17示出了根据本发明的另一个实施例的方法和设备。 [0050] - Figure 17 illustrates a method and apparatus according to another embodiment of the present invention.

具体实施方式 Detailed ways

[0051] 参见附图,其中在多个视图中类似的数字代表类似的解剖结构和部件,图1为患者的腹腔的局部视图,其中示出了具有食道1、胃2、十二指肠3、空肠4、回肠5、结肠6的胃肠道,以及具有肝脏、包含胆囊8的胆管树7、胰管9、以及乏特氏壶腹的十二指肠大乳头10 (胆汁和胰液穿过其正常地进入十二指肠3)的肝胆系统,以及用于转移被排到患者肠道中的胆胰液的设备11。 [0051] Referring to the drawings, wherein like numerals in the several views similar anatomical structures and components, FIG. 1 is a partial view of a patient's abdominal cavity, the esophagus is shown having 1, 2 stomach, duodenum 3 , 4 jejunum, ileum 5, 6 of the colon of the gastrointestinal tract, as well as having a liver, gall bladder biliary tree comprising 8 7 9 duct, ampulla of Vater and the duodenal papilla 10 (through the bile and pancreatic juice which normally into the duodenum 3) of the hepatobiliary system, and a transfer device 11 is discharged to the intestinal bile pancreatic juice patient.

[0052] 根据实施例,设备11包括优选柔性的管状构件12,所述管状构件12具有内部食物隔离空间13和至少近侧密封部分14,所述近侧密封部分14能够接合肠壁以防止肠壁在管状构件12和肠壁之间流动。 [0052] According to an embodiment, the device 11 preferably comprises a flexible tubular member 12, the tubular member 12 has an inner space 13 and the food isolation seal at least a proximal portion 14, the proximal portion 14 can engage the sealing wall in order to prevent intestinal walls of the flow between the tubular member 12 and the intestinal wall. 管状构件12还形成近侧开口端16和远侧开口端17,所述近侧开口端16能够接纳食物流并将其引导至食物隔离空间13中,所述远侧开口端17能够从食物隔离空间13释放食物流。 The tubular member 12 is also formed in the proximal open end 16 and a distal open end 17, a proximal open end 16 is capable of receiving a flow of food and the food is guided to the isolation space 13, the distal end opening 17 can be isolated from the food space 13 to release the food stream. 管状构件12的外表面18以形成侧向开放式胆汁隔离腔19的方式成型,所述侧向开放式胆汁隔离腔19能够与肠壁的相邻部分一起限定胆汁隔离空间19。 The outer surface 18 of the tubular member 12 to form an isolated bile manner laterally open cavities 19 forming the lateral open chamber 19 can be isolated from the bile of bile insulation space 19 is defined together with the adjacent portion of the intestinal wall.

[0053] 设备11还包括食物套管部分21,所述食物套管部分21从柔性的管状构件12的远侧开口端17朝远侧延伸并具有开放式远侧食物套管端22。 [0053] The apparatus 11 further comprises a sleeve portion 21 of food, the food portion 21 from the distal sleeve of the flexible tubular member 12 extending distally open end 17 and having an open distal end 22 of cannula food. 食物套管部分21在内部限定食物输送空间23。 Food sleeve portion 21 within the space 23 defined food conveyed.

[0054] 此外,胆汁转移导管24可从胆汁隔离腔19沿远侧方向延伸并具有开放式远侧胆汁导管端25。 [0054] In addition, the bile transfer conduit 24 may extend from a distal direction bile isolation chamber 19 and having an open distal end of the bile duct 25. 胆汁转移导管在内部限定与食物输送空间23隔离的胆汁输送空间26。 Bile transfer conduit defined internally with food conveying space 23 space 26 isolated from the bile transport.

[0055] 可将此设备例如经口插入和调配到乏特氏乳头区域10处的十二直肠中,以使得胆汁隔离腔19覆盖乏特氏乳头10以接纳胆胰液。 [0055] This device may be, for example, oral formulations, and is inserted into the duodenum papilla of Vater 10 region, to isolate chamber 19 such that the bile cover Vater's papilla 10 to receive bile pancreatic juice. 按照这种定位,设备11允许将食物或食糜与肠壁在管状构件12远侧的区域中隔离,同时允许将胆汁从胆汁隔离腔19转移到独立于与食糜隔离的区域的位置,且无需进入奥狄括约肌。 In this position, the device 11 allows the chyme food or with the intestinal wall in the region of the isolation distal tubular member 12, while allowing the transfer of bile from the bile into the isolation chamber 19 independently of the position of chyme isolated regions, and without entering the sphincter of Oddi.

[0056] 根据实施例,管状构件12能够支架,所述支架能够被锚定在小肠中,尤其是胆胰液正常进入肠的乏特氏乳头10处的十二指肠3中,并且能够捕集胆胰液并将其引导至胆汁转移导管24中。 Duodenum [0056] According to an embodiment, the tubular member 12 can be a bracket capable of being anchored in the small intestine, especially the bile into the intestine of normal pancreatic juice Vater's papilla at 103, and is capable of trapping bile pancreatic juice and bile guided to the transfer conduit 24.

[0057] 在示例性实施例中,胆汁隔离腔19包括径向外部环形腔,所述径向外部环形腔围绕胆汁隔离空间20形成并且由径向突出的近侧管腔密封部分14和径向突出的远侧管腔密封部分15轴向界定。 [0057] In an exemplary embodiment, the bile isolation chamber 19 includes a radially outer annular chamber, said radially outer annular chamber 20 is formed around the insulation space and bile proximal lumen by the sealing portion 14 and a radially projecting radially projecting distal sealing portion 15 axially defines a lumen.

[0058] 管腔密封部分14,15可从初始收缩的径向较小构型膨胀至膨胀的径向较大构型,所述初始收缩的径向较小构型允许将设备11经管腔(经口)引入和输送到乏特氏乳头10处的所选十二指肠部分,所述膨胀的径向较大构型允许管腔密封部分14,15紧密地接合管腔壁并且将管状构件12锚定到管腔壁。 [0058] 14, 15 radially collapsible from an initial configuration smaller lumen of the sealing portion is expanded to a radially expanded configuration larger, the initial shrinkage radially smaller configuration allows the device 11 administered chamber (oral) is introduced and conveyed to the selected portions of the duodenal papilla of Vater 10, the expanded radially larger lumen configuration allows the sealing portions 14, 15 tightly engages the tubular and the lumen wall anchoring member 12 to the lumen wall.

[0059] 为此,管腔密封部分14,15可包括可膨胀式球囊区段,所述可膨胀式球囊区段可通过注入膨胀流体例如盐水溶液、或固化膨胀剂例如硬化聚合物泡沫或糊剂而永久性地膨胀。 [0059] To this end, the lumen of the sealing portions 14, 15 may comprise an inflatable balloon section, the inflatable balloon expandable section by injecting a fluid such as saline solution, bulking agents such as hardened or cured polymer foam or paste and permanently expanded.

[0060] 根据实施例,远侧管腔密封部分15还可限定一个或多个胆汁通道孔27,所述胆汁通道孔27从胆汁隔离腔19延伸到胆汁转移导管24并将这两者放置成流体连通。 [0060] According to an embodiment, the distal lumen of the sealing portion 15 may also define one or more bile passage holes 27, the passage hole 27 extending from the bile bile isolation chamber 19 into the bile duct 24 and the transfer is placed in both the fluid communication.

[0061] 根据实施例,胆汁转移导管24的远侧开口端25定位在远侧开放式套管端22远侧的位置处。 [0061] According to an embodiment, the bile duct 24 transfers the distal end 25 of the opening 22 is positioned at a location distal to the distal open end of the sleeve. 这允许在柔性的管状构件12远侧的第一位置分配食物以使食物与肠壁接触,并且允许在第一位置更远侧的肠内第二位置分配胆汁或胆胰液,以使得胆汁与肠壁(例如,远侧空肠或回肠壁)接触,并且在食糜流已沿肠道移行且接触与胆汁隔离的肠道之后,与部分消化的食物或食糜流接触。 This allows the distribution of food 12 in the first position distal flexible tubular member into contact with the intestinal wall so that the food, in the first position and allow a more distal intestine in bile or bile second dispensing position pancreatic juice, bile and gut such walls (e.g., distal jejunum, or back wall) contact and, after intestinal digesta flow is transitional along and in contact with the intestinal bile isolated, partially digested food in contact with or chyme stream.

[0062] 根据另一个实施例(图2,3),胆汁转移导管24可包括外部套28,所述外部套28基本上与食物套管部分21同轴并且限定围绕食物套管部分21的环形胆汁输送空间26。 [0062] According to another embodiment (FIGS. 2 and 3), bile transfer conduit 24 may include an outer sleeve 28, the outer sleeve 28 is substantially coaxial with the food portion 21 and the sleeve portion 21 defines an annular sleeve surrounding the food bile transport space 26. 在此实施例中,远侧胆汁导管端25的位置取决于外部套28的长度并且可位于远侧食物套管端22的近侧的位置处,以使得: In this embodiment, the distal end position of the bile duct 25 depends on the length of the outer sleeve 28 and may be located at a position proximal to the distal 22 end of the food casing, such that:

[0063]-在管状构件12远侧的第一管道29中,食物流和胆汁流彼此隔离并且与肠壁隔离, [0063] - 29 in isolation, the food flow and bile flow conduit 12 of the first tubular member distal each other and isolated from the intestinal wall,

[0064]-在第一管道29远侧且从远侧胆汁导管端25朝远侧延伸的第二管道30中,胆汁与肠壁接触,而食物流仍与胆汁和肠壁隔离,并且 [0064] - and, bile duct 29 in contact with the first conduit 30 distal from the second distal end of the bile duct 25 extending distally with the intestinal wall, but is still isolated from food with bile flow and the intestinal wall, and

[0065]-在第二管道30远侧且从远侧食物套管端22朝远侧延伸的第三管道31中,食物流与残余的仍未被吸收的胆汁混合并且与肠壁接触(图3)。 [0065] - a second conduit 30 and distally from the sleeve distal bile mixed food 22 has not absorbed the third conduit 31, the flow of food and the residual end extending distally and in contact with the intestinal wall (FIG. 3).

[0066] 在可供选择的示例性实施例中(图2A),远侧胆汁导管端25的位置可位于远侧食物套管端22的近侧的位置处,以使得: [0066] In an alternative exemplary embodiment (FIG. 2A), the distal end 25 position of the bile duct may be located at a location proximal the distal end of the cannula food 22, such that:

[0067]-在管状构件12远侧的第一管道32中,食物流和胆汁流彼此隔离并且与肠壁隔离, [0067] - a first conduit 12 in the distal tubular member 32, the flow of food and bile flow and isolated from each other and isolated from the intestinal wall,

[0068]-在第一管道32远侧且从远侧食物套管端22朝远侧延伸的第二管道33中,食物流与胆汁混合,而食物流和胆汁仍与肠壁隔离,并且 [0068] - a first conduit 32 distally from a distal Food and 22 extending distally of the second conduit 33, the food is mixed with bile flow sleeve end, while the food is still isolated from the biliary flow and the intestinal wall, and

[0069]-在第二管道33远侧且从远侧胆汁导管端25朝远侧延伸的第三管道34中,食物和胆汁与肠壁接触。 [0069] - from the third conduit 34 and the distal end of the bile duct 25 extending distally, the food in contact with the intestinal wall and bile duct 33 distal the second.

[0070] 在可供选择的实施例中(图4),胆汁输送空间26由食物套管部分21的外表面35和周围肠壁部分限定,以使得胆汁以与食物流隔离但与肠壁接触的方式从管状构件12朝远侧流入肠道36中。 [0070] In an alternative embodiment (FIG. 4), bile transport space 26 from the outer surface of the food portion 21 of the sleeve 35 and the peripheral wall portion defining such bile in contact with the food, but isolated from the flow with the intestinal wall way from the tubular member 12 flows into the intestinal tract 36 distally.

[0071] 根据示例性实施例(图5),胆汁转移导管24包括布置在食物套管部分21外部的导管,从而允许隔离的胆汁独立于肠壁和食糜或食物流动。 [0071] According to an exemplary embodiment (FIG. 5), bile transfer conduit 24 comprises a sleeve portion 21 disposed outside of the food conduit, thereby allowing the isolation of bile and intestinal chyme or independent of food flow.

[0072] 在此实施例中,远侧胆汁导管端25的位置取决于外部导管的长度并且可位于远侧食物套管端22的远侧的位置处,以使得: [0072] In this embodiment, the distal end position of the bile duct 25 depends on the length and may be located outside of the catheter 22 at a location distal a distal end of the food casing, such that:

[0073]-在管状构件12远侧的第一管道37中,食物流和胆汁流彼此隔离并且与肠壁隔离, [0073] - a first conduit 12 in the distal tubular member 37, the flow of food and bile flow and isolated from each other and isolated from the intestinal wall,

[0074]-在第一管道37远侧且从远侧食物套管端22朝远侧延伸的第二管道38中,食物流接触肠壁,而胆汁仍与食物和肠壁隔离,并且 [0074] - in the second conduit and the first conduit 37 distally from the distal end of the cannula 22 food 38 extending distally, contacts the intestinal wall flow of food, bile and food remains isolated from the intestinal wall, and

[0075]-在第二管道38远侧且从远侧胆汁导管端25朝远侧延伸的第三管道39中,胆汁与残余的仍未被吸收的食物混合并且与肠壁接触(图5)。 [0075] - a second conduit 38 and distally from the distal end 39 of the bile duct not been absorbed in the food, the residue mixed with bile third conduit 25 extends distally and is in contact with the intestinal wall (FIG. 5) .

[0076] 在可供选择的示例性实施例中(未示出),远侧胆汁导管端25的位置可位于远侧食物套管端22的近侧的位置处,以使得: [0076] In an alternative exemplary embodiment (not shown), the position of the distal end of the bile duct 25 may be located at a position proximal to the distal 22 end of the food casing, such that:

[0077]-在管状构件12远侧的第一管道中,食物流和胆汁流彼此隔离并且与肠壁隔离, [0077] - a first conduit 12 in the distal tubular member, the flow of food and bile flow and isolated from each other and isolated from the intestinal wall,

[0078]-在第一管道远侧且从远侧胆汁导管端25朝远侧延伸的第二管道中,胆汁与肠壁接触,而食物流仍与胆汁和肠壁隔离,并且 [0078] - the flow of food and bile and remain isolated from the intestinal wall and in the first conduit distal bile duct in contact with the second distal end of the bile duct 25 extending distally with the intestinal wall, and

[0079]-在第二管道远侧且从远侧食物套管端22朝远侧延伸的第三管道中,食物与残余的仍未被吸收的胆汁混合并且与肠壁接触。 [0079] - and the second conduit distal from the distal end of the cannula food third conduit 22 extending distally bile residual mixed with food is absorbed and not in contact with the intestinal wall.

[0080] 根据另一个实施例,食物套管部分可从可结合图1和2的实施例所述进行构造的近侧管腔密封部分14向近端延伸,由此形成可经口插入胃肠道并且锚定在其某个位置的十二指肠套管装置,其中近侧管腔密封部分定位在例如乏特氏乳头10近端(上游)的若干厘米处。 [0080] According to another embodiment, the food of the sleeve portion may be a proximal portion configured to seal the lumen 14 extends proximally from a connection with the embodiment of Figures 1 and 2, thereby forming insertable orally parenterally and channel means duodenal cannula at one of its anchored position, wherein the sealing portion is positioned proximal lumen at the proximal end 10, for example, several centimeters Vater's papilla (upstream).

[0081] 根据示例性实施例,胆汁转移导管24的远侧开口端25可在远侧开放式套管端22近端的某个位置处通入食物套管部分21内,以使得(当将所述设备调配到患者的胃肠道中时): [0081] According to an exemplary embodiment, the bile transfer conduit 24 distally open end 25 can pass into the food portion of the inner sleeve 21 at a location 22 at the proximal end of the cannula distal open end, such that (when the the deployment apparatus to the patient's gastrointestinal tract):

[0082]-在管状构件12远侧的第一管道中,胆胰液和食物流彼此隔离并且与管腔壁隔离; [0082] - a first conduit 12 in the distal tubular member, pancreatic juice and bile flow of food isolated from each other and isolated from the lumen wall;

[0083]-在第一管道远端的第二管道中,胆胰液与食物流混合,但仍与管腔壁隔离; [0083] - a second conduit in the distal end of the first conduit, pancreatic juice and bile flow mixing food, but still isolated from the lumen wall;

[0084]-在第二管道远端的第三管道中,食物和胆胰液与肠壁接触。 [0084] - a second conduit in the distal end of the third conduit, the food in contact with the intestinal wall pancreatic juice and bile.

[0085] 根据另一个示例性实施例(图13),设备11包括在近端41和远端43之间延伸的胆汁引流导管40,所述近端41具有支架42以连接胆管树7中的胆汁引流导管40,所述远端43与管状构件12的胆汁隔离腔19以流体连通的方式连接。 [0085] According to another exemplary embodiment (FIG. 13), device 11 comprises a biliary drainage conduit 40 between the proximal 41 and distal ends 43 extending to the proximal end 41 having a bracket 42 connected to the biliary tree. 7 biliary drainage catheter 40, the distal end 4319 connected in fluid communication with a bile manner isolated cavity of the tubular member 12. 这允许选择性地捕集胆管树7内的胆汁和/或胰液并将其引导至胆汁隔离腔19中。 This allows the selective capture of bile in the biliary tree 7 and / or the guide into the bile and pancreatic juice isolation chamber 19.

[0086] 设备11可包括外部套44,所述外部套44在管状构件12之上部分地延伸并以在外部套44和管状构件12限定环形胆汁隔离空间45的方式与其连接,以使得胆汁隔离空间与肠壁隔离。 [0086] Device 11 may include an outer sleeve 44, the outer sheath 44 partially extends over the tubular member 12 and outer sleeve 44 in the manner and the tubular member 12 defines an annular space 45 is isolated from the bile connected thereto, such that the bile isolate space and isolated from the intestinal wall. 外部套44具有通入胆汁隔离空间45中并且形成上述胆汁引流导管40的侧向分支。 Outer sleeve 44 having a side branch into the bile insulating space 45 is formed above and biliary drainage conduit 40. 根据实施例,胆汁引流导管40的近端41可定位并锚定在胆总管与胰管9的联接位置下游的胆总管中,以使得将胆汁和胰液一起引流到胆汁隔离空间45中。 According to an embodiment, the proximal end 40 of the biliary drainage catheter 41 may be positioned and anchored in the coupling position of the common bile duct and the pancreatic duct downstream of the common bile duct 9, so that together with the drainage of bile and pancreatic juice into the bile in the insulating space 45. 作为另外一种选择,胆汁引流导管40的近端41可定位并锚定在胆总管与胰管9的联接位置上游的胆总管中,以使得仅将胆汁引流到胆汁隔离空间45中,而胰液可自然地排到十二指肠3中并且在管腔壁和外部套44的外表面之间的间隙中流入肠。 Alternatively, the proximal end 40 of the bile drainage catheter 41 may be positioned and anchored in the common bile duct with bile duct upstream of the position of the coupling 9, so that only the isolated bile drainage space 45 into the bile, pancreatic juice and naturally discharged to the intestinal duodenum 3 and flows into the gap between the lumen wall and the outer surface of the outer jacket 44.

[0087] 图14示出了另一个示例性实施例,其中外部套44可限定胆汁隔离空间20和单独的胰液隔离空间46,所述胰液隔离空间46与胆汁隔离空间隔离并且具有距远侧胆汁导管端25 —距离的胰液出口47。 [0087] FIG. 14 illustrates another exemplary embodiment, wherein the outer sleeve 44 may define a space 20 isolated from the bile and pancreatic juice separate insulation space 46, space 46 isolated from the pancreatic juice and bile from the insulation space and having a distal bile isolation end of the conduit 25 - pancreatic juice from the outlet 47. 胆汁引流导管40的近侧部分可为分叉的,以限定胆汁引流端41和胰液引流端48,所述胆汁引流端41可定位并锚定在胆总管与胰管9的联接位置上游的胆总管中,所述胰液引流端48可定位在胰管9中。 Biliary drainage catheter proximal portion 40 may be bifurcated to define pancreatic juice and bile drainage drainage end 41 end 48, the biliary drainage end 41 may be positioned and anchored in the coupling position upstream of the common bile duct and the bile duct 9 manifold, the pancreatic juice drainage end 48 may be positioned in the duct 9. 胆汁引流导管40还可包括内部隔膜51,所述内部隔膜51从分叉位置延伸到胆汁隔离空间45和胰液隔离空间46,以使得将胆汁引流到胆汁隔离空间45中,而将胰液引流到胰液隔离空间46中。 Biliary drainage catheter 40 may further include an inner diaphragm 51, the diaphragm 51 extends from the inner diverging space 45 into the bile and pancreatic juice isolation insulating space 46, such that the biliary drainage insulating space 45 into the bile, pancreatic juice and the drainage of the pancreatic juice insulating space 46.

[0088] 根据实施例,胰液出口47直接布置在食物隔离空间13上,以使得胰液与食物流大致在它们接触的自然位置混合,但与肠壁隔离(图14)。 [0088] According to an embodiment, secretin outlet 47 arranged directly on the food insulation space 13, so that the flow of pancreatic juice and food are mixed in a substantially natural position they are in contact, but the isolation wall (FIG. 14).

[0089] 根据本发明的另一个方面,设备11可包括在漏斗形近侧开口端50和远侧开口端52之间延伸的近侧套管49 (示于例如图1和2A中),所述漏斗形近侧开口端50能够例如通过与幽门适形连接而锚定在胃2内,所述远侧开口端52连接到管状构件12的近侧孔16。 [0089] According to another aspect of the invention, apparatus 11 may include a funnel-shaped proximal opening in the proximal end of the sleeve 49 extending between end 50 and a distal opening 52 (shown in FIGS. 1 and 2A for example), the end of said funnel-shaped proximal opening 50 can be formed for example by suitable connecting pyloric anchored in the stomach 2, the open distal end of the tubular member 52 is connected to the proximal aperture 12 of 16. 近侧套管49可锚定设备11以较好地对抗蠕动力,并且可收集容纳在胃2中的食物并将其在不接触肠壁的情况下引导至食物隔离空间13中。 Food proximal sleeve 49 may be anchored to device 11 against the better creep strength, and may be housed in the collection of gastric 2 and guided to the isolation space 13 in food without contacting the intestinal wall.

[0090] 作为另外一种选择或除此之外,为了抵抗作用在设备11上的蠕动力,可例如通过胃线圈53将所述设备11锚定在胃肠道中,所述胃线圈53可从延展构型(能够将其经口或经鼻输送到胃2内)弹性变形为旋拧弓形或圆形构型(能够适形地接合胃2以便对连接到管状构件12的近端的锚定线54提供锚定)(图11)。 [0090] Alternatively or in addition, in order to resist peristaltic forces acting on the device 11, coil 53 may be, for example, through the stomach 11 to anchor the device in the gastrointestinal tract, from the stomach coil 53 extended configuration (which can be conveyed orally or nasally into the stomach 2) screwed to the elastically deformable arcuate or circular configuration (being able to conform to the stomach 2 to engage the proximal end of the tubular member 12 is connected to the anchor providing an anchor line 54) (FIG. 11).

[0091] 在图12所示的另一个示例性实施例中,可例如通过T形箍将锚定线54连接到先前在胃壁中形成的折襞55。 [0091] In another exemplary embodiment illustrated in FIG. 12, may be connected, for example via a T-shaped collar to the anchor line 54 previously formed in the stomach wall 55 of the plication.

[0092] 在图6所示的另一个示例性实施例中,可通过粘膜下带56将设备11锚定到肠壁,所述粘膜下带56插入管腔壁中并且完全围绕其延伸,由此形成锚定环以在肠壁中产生瓶颈部分,所述瓶颈部分能够接合形成于例如管状构件12的管腔密封部分14,15中的一者内的相应环形锚定凹槽57。 [0092] In another exemplary embodiment illustrated in FIG. 6, by the device 56 with submucosal anchored to wall 11, with the mucous membrane 56 is inserted into the lumen wall extends around and completely, by the this formed the anchor ring in the intestinal wall to produce a neck portion, the neck portion is formed, for example, can engage the respective annular sealing portions 14, 15 in the lumen of the tubular member 12 of one anchoring groove 57.

[0093] 图7示出了另一个示例性实施例,其中可通过胃支架58和附接的可弹性膨胀式(可能地形状记忆)弓形件59将设备11锚定在胃肠道中,所述弓形件59能够与胃2形成适形连接。 [0093] FIG. 7 shows another exemplary embodiment, wherein the (possibly shape memory) 59 bracket 11 anchor the device in the GI tract through the stomach and the attachment bracket 58 may be elastically expandable type, the can be formed arcuate member 59 connected to the conformal 2 stomach.

[0094] 图8示出了另一个示例性实施例,其中可通过T形箍60将设备11锚定在胃肠道中,所述T形箍60从肠的内部击送到肠壁中由此形成固定位置并且与管状构件12的近端连接。 [0094] FIG. 8 shows another exemplary embodiment wherein the cuff 60 through a T-shaped anchor device 11 in the gastrointestinal tract, the T-shaped ferrule 60 from the inside of the intestine to the intestinal wall thereby strike forming a fixed position and is connected to the proximal end of the tubular member 12.

[0095] 图9和9A示出了另一个示例性实施例,其中可通过具有多个锚定倒钩62的环形锚定部分61将设备11锚定在胃肠道中,所述倒钩62可从静止位置移动(例如,旋转)到工作位置,在所述静止位置中倒钩62容纳在锚定部分61的圆周内以允许设备11的无阻挡腔内输送,在所述工作位置中倒钩62径向向外突出,由此刺穿管腔壁并因而将设备11锚定到管腔壁。 [0095] FIGS. 9 and 9A illustrate another exemplary embodiment, wherein the anchoring by having a plurality of annular barbs 62 of the anchor portion 61 anchors the device 11 in the gastrointestinal tract, the barbs 62 may rest position (e.g., rotation) from the operative position to the barbs received in the rest position 62 to allow an unobstructed cavity delivery device 11, the barbs in the working position in the inner circumferential portion 61 of the anchor 62 radially outwardly, thereby piercing the lumen wall and thus anchoring the device 11 to the lumen wall.

[0096] 在图10-10C所示的另一个示例性实施例中,可通过具有一个或多个锚定孔64的管状锚定部分63将设备11锚定在胃肠道中,所述锚定孔64设计为面向肠壁部分并且能够允许将这些肠壁部分牵拉到孔64内并与其固定。 [0096] In another exemplary embodiment illustrated in FIG 10-10C, by having one or more anchor holes 64 of the tubular portion 63 of the anchoring device 11 is anchored in the gastrointestinal tract, the anchor holes 64 designed to face the wall portion and can allow these wall portions pulled into the bore 64 and secured thereto. 可提供用于从管状锚定部分63内部抽吸管腔壁部分并将其牵拉到锚定孔64内的腔内抽吸装置55、以及用于产生管腔壁部分的永久性(蘑菇头型)溶胀以防止其从锚定孔64缩回的装置和方法。 May be provided for anchoring the tubular portion 63 from the interior portion of the chamber wall and the suction tube is pulled into the cavity of the anchoring holes 64 of the suction means 55, and for generating a permanent part of the lumen wall (mushroom head type) swollen method and apparatus to prevent it from the anchor hole 64 is retracted. 用于产生管腔壁部分的永久性溶胀的这些装置和方法可包括将膨胀剂或硬化剂粘膜下注入或将塑性小球(聚(甲基丙烯酸甲酯)PMMA)引入先前已牵拉穿过锚定孔64的组织部分中。 These apparatus and methods for generating a permanent swelling of the lumen wall portion may include injection or plastic beads (poly (methyl methacrylate) of PMMA) has been pulled through the previously introduced into the mucosal swelling agents or hardener tissue portion 64 in the anchor hole.

[0097] 参照图15A和15B,外部套65可设置有侧向孔66,所述侧向孔66能够被放置在奥狄括约肌之上以限定用于隔离排到十二指肠内的胆汁的空间。 [0097] Referring to FIGS. 15A and 15B, the outer sleeve 65 may be provided with a lateral hole 66, the lateral hole 66 can be placed over the spacer to define a sphincter of Oddi in the duodenum bile discharged space. 在围绕侧向孔66的边缘处以及在围绕外部套65的近端67的边缘处,可将加固网68粘合到套管以提供缝合区域的加固。 Around the lateral edge of hole 66 and at the edge of the outer sleeve 65 around the proximal end 67, the reinforcing mesh may be adhered to the sleeve 68 to provide a region of reinforcement stitching. 此外,可将外科用毡条69在加固网68和缝合面积的区域中施加到外部套65的外部。 Further, surgical outer jacket 69 is applied to the exterior in the region of 65 plus 68 and fixed with sutures in the area of ​​felt strips. 可将近端边缘67和侧向孔66的边缘缝合到十二指肠壁,以使得侧向孔66设置在奥狄括约肌周围,从而与管腔壁形成无泄漏连接,由此适于限定出食物流和胆汁隔离空间,如此前所述。 Proximal edge 67 and side edge apertures 66 may be sewn to the duodenal wall, so that lateral apertures 66 disposed around the sphincter of Oddi, thereby forming a leak-free connection to the lumen wall, thereby defining a suitable food bile flow and spatial isolation, as previously described. 此外,可将由外科用毡制成的连续或不连续外部纱布70布置在十二指肠壁外部的缝合区域上以防止缝线切割浆膜和牵拉出管腔壁。 Further, by continuous or discontinuous external gauze 70 is arranged on the outside of the duodenal wall to prevent the surgical suture region made of felt and pulled out of the serosal suture cutting lumen wall.

[0098] 根据本发明的另一个示例性实施例,可将鸭嘴形出口阀(未详细示出)布置在食物套管部分21和/或胆汁转移导管24的远端区域中,以防止食糜返流和感染风险。 [0098] According to another exemplary embodiment of the present invention, the duckbill valve outlet (not shown in detail) arranged in and / or the distal region 24 of the food transfer conduit bile sleeve portion 21 to prevent food Mi reflux and the risk of infection.

[0099] 图16示出了用于隔离食物、胆汁、胃分泌液和十二直肠分泌液的设备的另一个示例性实施例,其中所述设备包括三个套管72,73,74,所述套管72,73,74同轴地插入彼此之中并且具有位于不同位置的不同近侧入口和位于不同位置的不同远侧出口以在指定位置隔离和混合分泌液。 [0099] FIG. 16 illustrates another exemplary embodiment for isolation of food, bile, gastric secretion apparatus and the secretion of the duodenum, wherein the apparatus comprises three sleeves 73, 74, the said sleeve 73, 74 is coaxially inserted into each other and have different at different positions proximal inlet and a distal outlet to isolate different location and at a specified mixing exudates at different positions.

[0100] 独立于所述设备实施例,本发明还涉及用于转移被排到患者肠道中的胆胰液的方法,所述方法包括: [0100] Example embodiments of said apparatus independent of, the present invention also relates to a method intestinal bile pancreatic juice for transferring a patient is discharged, the method comprising:

[0101] A)在乏特氏壶腹区域处形成位于设备和肠壁之间的胆汁隔离空间; [0101] A) forming a bile insulating space located between the device and the intestinal wall in the region of the ampulla of Vater;

[0102] B)将食物流与肠壁在胆汁隔离空间远端的区域中分离; [0102] B) separating the food stream with the intestinal wall in the region of the distal end of the bile insulating space;

[0103] C)将隔离的胆汁从胆汁隔离空间转移到其中食物流与肠壁分离的区域的远侧的位置。 [0103] C) isolating the bile from the bile insulation space to a transfer position where the distal wall of the food stream of separate regions.

[0104] 根据实施例,转移隔离的胆汁的步骤包括如下步骤:将胆汁转移导管在腔内从胆汁隔离空间沿远侧方向延伸到其中食物流与肠壁分离的区域的远侧的位置。 [0104] According to the procedure includes the following steps embodiment, the transfer of isolated bile: bile transfer conduit extends within the cavity from the bile insulation space wherein a distal direction to the distal location food stream separate regions of the intestinal wall.

[0105] 根据另一个示例性实施例(图17),转移隔离的胆汁的步骤包括如下步骤:通过肠-肠吻合或通过内源性腔内旁路71 (具有吻合到胆汁隔离空间中的肠壁的近端和吻合到肠的远侧靶位置的远端)在胆汁隔离空间中的肠壁与肠的远侧靶位置之间形成直接管腔连通,以使得通过旁路71隔离和转移胆汁,同时通过食物套管部分21隔离和输送食物流。 [0105] According to another exemplary embodiment (FIG. 17), the step of transferring the isolated bile comprising the steps of: through the gut - anastomosis or bypass cavity 71 by endogenous (to coincide with the intestinal bile insulating space direct communication with a lumen formed between the distal and proximal end wall of the intestine distal to the anastomosis target site) the target position of the distal wall of the intestine in bile isolated space, through the bypass 71 so that the isolation and transfer of bile , while the flow of food through the sleeve portion 21 and spacer transporting food.

[0106] 尽管已详细描述了本发明的优选实施例,但申请人的目的并不是将权利要求的范围限于这些特定实施例,而是涵盖属于本发明的范围内的所有修改形式和替代构造。 [0106] Although described in detail preferred embodiments of the present invention, but is not the intention of the applicant to limit the scope of the claims to these specific embodiments, but encompasses all modifications and alternate constructions falling within the scope of the present invention.

Claims (15)

1.一种用于转移被排到患者肠道中的胆胰液的设备(11),包括管状构件(12),所述管状构件(12)具有: -内部食物隔离空间(13)和近侧密封部分(14),所述近侧密封部分(14)能够接合肠壁以防止食物在所述管状构件(12)和所述肠壁之间流动, -近侧开口端(16)和远侧开口端(17),所述近侧开口端(16)能够接纳食物流并将食物流引导至所述食物隔离空间(13)中,所述远侧开口端(17)能够从所述食物隔离空间(13)释放食物流, -侧向开放式胆汁隔离腔(19),所述侧向开放式胆汁隔离腔(19)能够与肠壁的相邻部分一起限定胆汁隔离空间(19),所述设备(11)还包括: -食物套管部分(21),所述食物套管部分(21)从柔性的管状构件(12)的远侧开口端(17)朝远侧延伸并具有远侧开放式食物套管端(22),所述食物套管部分(21)在内部限定食物输送空间(23), -胆汁转移导管(24),所述胆汁转移导管(24)从所述 An apparatus for transferring bile pancreatic juice is discharged to the intestinal tract of a patient (11), comprising a tubular member (12), the tubular member (12) having: - food inside the insulation space (13) and a proximal seal (14), the proximal sealing portion (14) can engage to prevent flow between the wall (12) and the food in the wall of the tubular member, - a proximal open end (16) and a distal opening end (17), said proximal open end (16) capable of receiving a flow of food and food flow to the food in the insulation space (13), said distal end opening (17) can be isolated from the food space (13) to release a flow of food, - the open side of bile isolation chamber (19), said lateral open chamber bile spacer (19) can define bile insulation space (19) together with the adjacent wall portion of the apparatus (11) further comprises: - food sleeve portion (21), said food sleeve portion (21) extends from the open distal end (17) of the flexible tubular member (12) having a distal and distally open food formula sleeve end (22), said food sleeve portion (21) defined inside the food conveying space (23), - transferring the bile duct (24), the bile transfer conduit (24) from the 胆汁隔离腔(19)沿远侧方向延伸并具有远侧开放式胆汁导管端(25),所述胆汁转移导管在内部限定与所述食物输送空间(23)隔离的胆汁输送空间(26), -管状构件外部套(44),所述管状构件外部套(44)在所述管状构件(12)之上延伸并与其连接,所述连接方式使得在所述管状构件外部套(44)和所述管状构件(12)之间限定环带胆汁隔离空间(45),所述管状构件外部套(44)具有通入所述胆汁隔离空间(45)中并形成所述胆汁引流导管(40)的侧向分支。 Bile isolation chamber (19) extends and having an open distal end of the bile duct (25) in a distal direction, the bile transfer conduit defining the inside of the food conveying space (23) isolated bile conveying space (26), - a tubular outer sleeve member (44), said outer tubular sheath member (44) extending over the tubular member (12) and connected, in a manner such that the outer jacket of the tubular member (44) and the defined between said tubular member (12) annulus bile insulation space (45), said outer tubular sheath member (44) having the bile into the insulation space (45) and forming the biliary drainage catheter (40) lateral branches.
2.根据权利要求1所述的设备(11),其中所述胆汁转移导管(24)的远侧开口端(25)定位在所述远侧开放式套管端(22)远侧的位置处。 At position 2. The apparatus (11) according to claim 1, wherein the distal open end of the bile transfer conduit (24) (25) is positioned in the distal open end of the sleeve (22) distal .
3.根据权利要求1所述的设备(11),其中所述胆汁转移导管(24)的远侧开口端(25)能够在所述远侧开放式套管端(22)近侧的位置处通入所述食物套管部分(21)中。 3. The apparatus (11) according to claim 1, wherein the distal open end of the bile transfer conduit (24) (25) capable of the cannula at a position distal open end (22) proximal to food into the sleeve portion (21).
4.根据权利要求1所述的设备(11),其中所述远侧开放式套管端(22)能够在所述胆汁转移导管(24)的远侧开口端(25)近侧的位置处通入所述胆汁转移导管(24)中。 4. The apparatus (11) according to claim 1, wherein the open position of the distal end of the cannula of formula (22) can be open distal end (25) in the bile transfer conduit (24) of the proximal the transfer into the bile duct (24).
5.根据权利要求1所述的设备(11),其中所述管状构件(12)为能够锚定在小肠中的支架,在所述小肠处胆胰液正常进入所述肠,并且所述支架能够捕集所述胆胰液并将其引导至所述胆汁转移导管(24)中,其中所述胆汁隔离腔(19)包括环形腔,所述环形腔围绕所述胆汁隔离空间(20)形成并且由径向突出的近侧管腔密封部分(14)和径向突出的远侧管腔密封部分(15)轴向界定。 5. The apparatus of claim 1 (11), wherein the tubular member (12) capable of anchoring the stent in the small intestine, the small intestine of the bile into the intestine of normal pancreatic juice, and the support can claim the bile and pancreatic juice trap guided to the bile transfer conduit (24), wherein the bile isolation chamber (19) comprises an annular chamber, said annular chamber surrounds the bile insulation space (20) and is formed by a proximal lumen radial sealing portion (14) projecting distal lumen and a radially projecting sealing portion (15) axially defined.
6.根据权利要求5所述的设备(11),其中所述管腔密封部分(14,15)能够从初始收缩的径向较小构型膨胀至膨胀的径向较大构型。 6. The apparatus (11) according to claim 5, wherein the sealing portion of the lumen (14, 15) radially collapsible from an initial configuration to an expanded smaller radially larger configuration.
7.根据权利要求6所述的设备(11),其中所述管腔密封部分(14,15)包括能够通过注入膨胀流体而永久性地膨胀的可膨胀式球囊区段。 7. The apparatus (11) according to claim 6, wherein the sealing portion of the lumen (14, 15) includes an expandable balloon section can be permanently expanded by injecting inflation fluid.
8.根据权利要求1所述的设备(11),其中所述胆汁转移导管(24)包括与所述食物套管部分(21)同轴的食物套管部分外部套(28),从而限定围绕所述食物套管部分(21)的环形胆汁输送空间(26)。 8. The apparatus (11) according to claim 1, wherein said bile transfer conduit (24) comprises a sleeve portion and said food (21) coaxial with the sleeve portion of the outer jacket of the food (28), thereby defining around the food sleeve portion (21) an annular space bile transport (26).
9.根据权利要求1所述的设备(11),其中所述胆汁转移导管(24)包括布置在所述食物套管部分(21)外部的导管。 9. The apparatus (11) according to claim 1, wherein said bile transfer conduit (24) comprises a conduit disposed on the outside of the food sleeve portion (21).
10.根据前述权利要求中任一项所述的设备(11),包括在近端(41)和远端(43)之间延伸的胆汁引流导管(40),所述近端(41)能够布置在胆管树(7)中,所述远端(43)与所述胆汁隔离腔(19)以流体连通的方式连接。 According to claim 10 capable device (11) according to any one of claims, comprising a biliary drainage catheter (40) extending between the proximal end (41) and a distal end (43), said proximal end (41) disposed in the biliary tree (7), said distal end (43) of the bile isolation chamber (19) fluidly connected to the communication.
11.根据权利要求1所述的设备(11),其中所述管状构件外部套(44)限定所述胆汁隔离空间(20)和单独的胰液隔离空间(46),所述胰液隔离空间(46)具有距所述远侧胆汁导管端(25) —距离的胰液出口(47),其中所述胆汁引流导管(40)的近侧部分为分叉的并形成胆汁引流端(41)和胰液引流端(48),并且所述胆汁引流导管(40)包括从所述分叉位置延伸到所述胆汁隔离空间(45)和胰液隔离空间(46)的内部隔膜(51)。 11. The apparatus (11) according to claim 1, wherein said outer tubular sheath member (44) defining the bile insulation space (20) and a separate pancreatic juice insulation space (46), said insulating space pancreatic juice (46 ) having a bile duct from said distal end (25) - pancreatic juice outlet (47) a distance, wherein the biliary drainage catheter (40) proximal portion is bifurcated and formed biliary drainage end (41) and draining pancreatic juice end (48), and the biliary drainage catheter (40) comprising a diverging section extending from the bile into the insulation space (45) and pancreatic juice insulating space (46) inside the separator (51).
12.根据权利要求11所述的设备(11),其中所述胰液出口(47)直接布置在所述食物隔离空间(13)上。 12. The apparatus (11) according to claim 11, wherein said pancreatic juice outlet (47) is arranged directly on the food in the insulation space (13).
13.根据权利要求1所述的设备(11),包括近侧套管(49),所述近侧套管在能够被锚定在胃⑵内的漏斗形近侧开口端(50)和连接到所述管状构件(12)的近侧孔(16)的远侧开口端(52)之间延伸。 13. The apparatus (11) according to claim 1, comprising a proximal cannula (49), the proximal sleeve can be anchored in the stomach ⑵ funnel-shaped proximal opening end (50) and the connection the distal proximal bore (16) to the tubular member (12) open end (52) extends between.
14.根据权利要求1所述的设备(11),包括用于将所述管状构件(11)锚定在胃肠道中的锚定装置,所述锚定装置选自: -胃线圈(53),所述胃线圈(53)能够从延展构型弹性变形为能够与胃(2)适形连接的旋拧弓形构型,以便提供用于连接到所述管状构件(12)的近端的锚定线(54)的锚定体, -锚定线(54)和多个T形箍,所述T形箍能够将所述锚定线连接到胃壁中的折襞(55), -粘膜下带(56),所述粘膜下带(56)能够插入管腔壁中以便在肠壁中形成锚定环、能够接合形成于所述管状构件(12)中的相应的环形锚定凹槽(57), -胃支架(58)和附接的可弹性膨胀式弓形件(59),所述可弹性膨胀式弓形件(59)能够与胃(2)形成适形连接, -T形箍(60),所述T形箍¢0)能够从肠的内部施加在肠壁中并且与所述管状构件(12)的近端连接, -环形锚定部分(61),所述环形锚定部分¢1)具有多个锚定倒钩(62),所述倒 14. The apparatus (11) according to claim 1, comprising means for the tubular member (11) in the anchoring means anchor the gastrointestinal tract, the anchoring means is selected from: - Stomach coil (53) the gastric coil (53) can be elastically deformed from the configuration as to be extended stomach (2) is adapted screw-connected arcuate configuration so as to provide for connection to the proximal end of the tubular member (12) of the anchor alignment (54) of the anchoring body, - the anchor lines (54) and a plurality of T-shaped ferrule, the ferrule can be T-shaped anchor line is connected to the plication (55) in the stomach wall, - submucosal belt (56), the submucosal band (56) can be inserted into the lumen wall so as to form a ring anchored in the intestinal wall, to engage the respective annular member formed in the tubular (12) in the anchoring groove ( 57), - gastric holder (58) and attached resiliently expandable bow of formula (59), said elastically expandable members bow of formula (59) can be connected to form a conformal, -T-shaped collar (stomach (2) 60), the T-shaped band ¢ 0) can be applied from the interior of the intestine and in the intestinal wall proximal end of the tubular member (12) is connected, - an annular anchoring part (61), the annular anchoring portion ¢. 1) having a plurality of anchoring barbs (62), the inverted (62)能够从缩回式静止位置运动到其中所述倒钩¢2)径向向外突出的工作位置, -管状锚定部分¢3)和用于产生管腔壁部分的永久性蘑菇头型肿胀、从而防止其从锚定孔¢4)缩回的装置,所述管状锚定部分¢3)具有一个或多个所述锚定孔(64),一个或多个所述锚定孔¢4)能够面向肠壁部分并且能够允许将这些肠壁部分牵拉到所述孔¢4)中并固定到其上, -具有能够缝合到十二指肠壁的近端和侧向孔¢6)的外部套(65),以使得所述侧向孔(66)围绕奥狄括约肌放置,所述外部套包括粘合到围绕所述侧向孔¢6)的边缘和围绕所述外部套(65)的近端(67)的边缘的加固网(68),所述加固网提供加固的缝合区域,将外科用毡条(69)在所述加固网(68)的区域中施加到所述外部套(65)的外部。 (62) can be retracted from the barb rest position into which the formula ¢ 2) radially outwardly projecting operating position, - the tubular portion of the anchor ¢. 3) for generating a lumen wall portion of the permanent mushroom head type swelling, thereby preventing the device from its retracted anchor holes ¢. 4), the tubular anchoring part ¢ 3) having one or more anchor holes (64), one or more anchor holes ¢ 4) capable of facing the wall portion and the wall portion to allow the drawing) in the hole ¢ 4 and secured thereto, - can be sewn into the duodenal wall having a proximal end and a lateral hole ¢ 6) outer sheath (65), such that the lateral apertures (66) disposed about the sphincter of Oddi, said outer sheath comprising an adhesive to said lateral aperture surrounding ¢ 6) around the outer edge of the sleeve and plus fixed proximal edge (67) (65) (68), providing said reinforcing mesh reinforcement stitching area, applied to the surgical reinforcing mesh in the region (68) of the felt strip (69) said external outer sleeve (65).
15.根据权利要求1所述的设备(11),包括鸭嘴形出口阀,所述鸭嘴形出口阀布置在所述食物套管部分(21)和所述胆汁转移导管(24)中的至少一者的远端区域中。 15. The apparatus (11) according to claim 1, comprising a duckbill valve outlet, the duckbill valve is disposed in said outlet food sleeve portion (21) and said transfer bile duct (24) at least one distal end region.
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